Characterizing liver cancer and chronic liver disease through sample collection

Deep Liver Phenotyping and Immunology Study

This study is trying to find early signs of liver cancer by collecting and comparing blood, urine, and liver samples from people with liver cancer and those with chronic liver disease.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of Oxford (other)
• Locations: 1 site (Oxford, Oxfordshire)
• Trial ID: NCT04946773 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify early biomarkers for hepatocellular carcinoma and cholangiocarcinoma by collecting blood, urine, and liver samples from patients. It will compare samples from individuals with liver cancer to those with chronic liver disease to understand the cancer-predisposing 'field effect'. The study will utilize techniques such as fine needle aspiration for minimally invasive sample collection and will analyze these samples through flow cytometry, molecular biology, and transcriptomic analysis. The ultimate goal is to develop a multi-parametric model for early cancer detection.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18 to 75 with either diagnosed liver malignancies or chronic liver disease.

Not a fit: Patients who are pregnant or unable to provide informed consent will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection of liver cancers, allowing for more effective treatment options.

How similar studies have performed: Other studies have shown promise in identifying biomarkers for liver cancers, but this approach may offer novel insights into the predisposing factors.

Eligibility criteria

Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years to 75 years.

Malignancy Cohort: extra inclusion criteria - Diagnosed with a malignancy or with clinical suspicion of a malignancy affecting the Liver or Biliary Tree.

Control cohort: extra inclusion criteria

\- Patients with confirmed chronic non-malignant hepatobiliary disease.

Additional Inclusion Criteria for Patients Undergoing optional Liver FNA

* Willing to undergo ultrasound guided liver FNA (unless specific contra-indications to the procedure apply).
* Has undergone appropriate clinical imaging of the upper abdomen (US/CT/MRI) within the last 12 months.
* Full blood count (FBC) and coagulation profile (Coag) checked within 30 days prior to FNA procedure (Baseline Visit).

Exclusion Criteria:

* Unable to consent.
* Pregnancy.
* Any concern by the investigator regarding the safe participation of the patient in the study; or investigator's consideration, for any other reason, that a patient is inappropriate for participation in the study.

Additional Exclusion Criteria for Patients Undergoing optional Liver FNA (These criteria will exclude a patient from having FNA as part of the study)

* Significant comorbid medical condition(s) which may in the opinion of the investigator increase the risk of an FNA Liver.
* Coagulopathy - International Normalized Ratio (INR) \>1.3, Prothrombin Time (PT) \>16 seconds, Platelet count \<100 x 10\^3/L.
* Known bleeding disorder (e.g. Haemophilia).
* Current use of an oral/injectable anticoagulant medication.
* Current use of an oral antiplatelet agent.
* The presence of ascites.

Where this trial is running

Oxford, Oxfordshire

• John Radcliffe Hospital — Oxford, Oxfordshire, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Rory J Peters — University of Oxford
• Study coordinator: Rory J Peters

Conditions: Hepatocellular Carcinoma, Cholangiocarcinoma, Early Detection